Non-invasive device for synchronizing chest compression and ventilation parameters to residual myocardial activity during cardiopulmonary resuscitation

ABSTRACT

A system for improving cardiac output of a patient suffering from pulseless electrical activity or shock and yet displays myocardial wall motion including: a sensor to detect myocardial activity to determine the presence of residual left ventricular pump function having a contraction or ejection phase and a filling or relaxation phase, a device to prompt the application of or apply a compressive force repeatedly applied to the chest based on the sensed myocardial activity such that the compressive force is applied during at least some of the ejection phases and is ceased during at least some of the relaxation phases to permit residual cardiac filling, thereby enhancing cardiac output and organ perfusion.

RELATED APPLICATION

This application is a divisional of U.S. patent application Ser. No.13/182,800 (U.S. Pat. No. 9,259,543) filed Jul. 14, 2011, which is acontinuation-in-part (CIP) of U.S. patent application Ser. No.12/685,289, (U.S. Pat. No. 8,870,797) filed Jan. 11, 2010, which is adivisional application of U.S. patent application Ser. No. 10/973,775,(U.S. Pat. No. 7,645,247) filed Oct. 25, 2004, and claims the benefit ofU.S. Provisional Patent Application No. 61/419,525 filed Dec. 3, 2010,the entirety of all of these applications are incorporated by reference.

BACKGROUND OF THE INVENTION

This invention relates generally to the field of cardiovascularmedicine, and in particular to the treatment of patients suffering froma spectrum of cardiac states, ranging from shock to pulseless electricalactivity, in which the patient appears to be lifeless and in cardiacarrest yet retains some mechanical activity in the myocardial wallmotion.

One common technique for treating persons suffering from cardiac arrestis the use of cardiopulmonary resuscitation (CPR). In this procedure,the patient's chest is repeatedly compressed, often in combination withperiodic ventilations. Administration of electrical countershock anddrugs intended to assist in restoration of cardiopulmonary function tochest compression and ventilation, constitutes advanced life support.For a variety of reasons, the effectiveness of CPR has been limited.Hence, devices or techniques which can improve the effectiveness of CPRare greatly needed.

In additional to sudden cardiac arrest, refractory-shock (which isreferred to herein as “shock”) is often fatal. For example, if notproperly stabilized, a person suffering from shock can progress intocardiac arrest, which, because it is not sudden in nature, is usuallyfatal. Emergency medicine and critical care practitioners approach thetreatment of shock principally by attempting to alleviate the causebecause there are no non-invasive techniques that may beneficial inassisting circulation. Hence, devices and techniques are also needed totreat those suffering from refractory shock and shock that isprogressing toward cardiac arrest.

There is no general consensus as to when it is the appropriate to startadministering CPR as the patient's blood pressure progressivelydecreases. This relates to a lack of demonstrated efficacy and concernthat chest compression may interfere with residual cardiac function,even though CPR may at some point be beneficial in shock patients asthey progress to cardiac arrest. Hence there a need for a device ortechnique to prevent CPR from interfering with residual cardiacfunction.

Unlike cardiac arrest caused by ventricular fibrillation, pulselesselectrical activity (PEA) is a heterogeneous entity with respect tocardiac function and hemodynamics. PEA is a clinical conditioncharacterized by unresponsiveness and lack of palpable pulse in thepresence of organized cardiac electrical activity. Pulseless electricalactivity has previously been referred to as electromechanicaldissociation (EMD). During PEA, electrical activity of the heart may ormay not be indicative of cardiac mechanical movements and particularlycardiac output.

Pulseless electrical activity is not necessarily a condition of completemechanical quiescence in the heart. In PEA, the heart may have a regularorganized electrical rhythm such as supraventricular or ventricularrhythms. These cardiac rhythms may not be associated with mechanicalactivity of the heart in PEA.

As an example of cardiac mechanical patterns during PEA, patients mayhave weak ventricular contractions and detectable aortic pressure—whichis a condition referred as pseudo-PEA. Various studies have documentedthat between 40-88% of patients with PEA had residual cardiac mechanicalactivity (pseudo-PEA). In pseudo-PEA, the patient may appear lifelessand without a pulse, despite some degree of residual left ventriclefunction and hemodynamics. The outcome of patients suffering PEA hastended to be worse than those in ventricular fibrillation, possiblyreflecting the potential of CPR chest compressions and residualmyocardial mechanical activity to interfere with each other's efficacy.Hence there is a need for a device or technique to enhance the efficacyof CPR in PEA.

BRIEF DESCRIPTION OF THE INVENTION

Disclosed herein are techniques and systems for treating those sufferingfrom a variety of myocardial pathophysiologic states ranging inhemodynamics from awake patients in refractory shock to those who appearto be lifeless, yet who still retain some degree of residual myocardialmechanical function. It has been observed when performing open chestcardiac massage, that coordinating compression and relaxation with theheart's residual mechanical activity often improves recovery of cardiacfunction. Extrapolating from this, if mechanical myocardial function ispresent but inadequate, as in PEA, external chest compressions shouldlikely be directed toward assisting cardiac ejection—that is compressingthe chest during its intrinsic contractions—and then releasing the chestso as not to interfere with ventricular filling. CPR that is notsynchronized with the heart's residual mechanical function may result inapplication of the compression phase when the left ventricle is tryingto fill, resulting in significantly decreased cardiac output on the nextejection secondary to the Frank-Starling Law. Interference withventricular filling by compression of the chest can be so deleteriousthat it can, in and of itself, cause complete loss of residualmyocardial function resulting in true cardiac arrest.

A system is disclosed here that detects residual myocardial activity inan apparently lifeless patient and outputs signals to trigger chestcompressions by mechanical chest compression devices; to audiblyindicate when to initiate such chest compressions, or to otherinterventions that benefit from synchronization with residual myocardialactivity. These other interventions may include but are not limited to:abdominal counter-pulsation, ventilation, phasic limb-compression,myocardial electrical stimulation, intravascular fluid shifting,intravascular balloon inflation-deflation, intra-esophageal orintra-pericardial balloon inflation, application of transthoracicelectromagnetic irradiation, and the like.

A method is disclosed here for improving the cardiac output of patientssuffering from a range of pathophysiologic states such as pulselesselectrical activity or shock, which having some residual myocardial wallmechanical activity. According to the method, residual myocardialactivity is sensed to determine the presence of residual ventricularphasic movement, with or without residual left or right ventricular pumpfunction, but having an apparent ejection phase and a relaxation phase.A compressive force is repeatedly applied based on the sensed myocardialactivity such that, for example, the compressive force is applied duringat least some of the ejection phases and is ceased during at least someof the relaxation phases to permit cardiac filling, thereby creating orenhancing cardiac output and organ perfusion. The synchronization withthe sensed myocardial activity may also be used when the patient's chestis actively lifted during decompression. In this way, the chances forimproving the outcome of patients suffering from shock or cardiac arrestare improved.

The compressive force may be applied over a variable range of timeintervals. For example, the compressive force may be applied for only acertain portion of the contraction or ejection phase, such as at thebeginning, middle or end. As another example, the compressive force maybe applied during each and every sensed contraction or ejection phase,or only during certain contraction or ejection phases.

The start of the chest compression and the duration of the compressioncan be adjusted to improve patient outcomes. For example, theadjustments to the start time or duration may be adjusted to optimizethe chest compressions or other phasic therapy, where the adjustment isbased on feedback of a patient condition or physiologic parameter duringone or more prior chest compressions. The feedback signal may, forexample, indicate a rate or amount of cardiac ejection or filling,cardiac output or other indicator of mechanical activity of the heart orarterial blood flow. The feedback signal is coupled to the therapy bylogic circuits so as to vary the synchronized phasic therapies, e.g.,chest compressions, and vary the application of the therapies. Byvarying the therapies and their application and subsequentlyre-measuring the feedback signals, the logic circuits can determinewhich synchronized therapy, or therapies, and pattern of synchronizedtherapy is optimal and most effective to improve cardiac ejection,cardiac output or otherwise improve the condition of the patient. Forexample, the logic circuit may vary each of the synchronized therapiesand combinations of therapies to determine which pattern of therapy ortherapies when synchronized with residual myocardial synchronizationresults in the greatest measured cardiac output or results in some othermeasurable condition that indicates that the phasic therapy(ies) arebeing applied optimally.

Electrical stimulation of the heart may be applied in conjunction withor in addition to chest compressions. The electrical stimulations may besynchronized with electrical signals (ECG/EKG) of the inherentheartbeat, which may be slow and weak, or if there are no regularelectrical heart signals, with pulsatile flow or myocardial movements.For example, the electrical stimulation may be synchronized witharterial pulses, such as aortic pressure (AoP), based on detectedpulsatile pressure, blood flow, or myocardial movements.

Ventilations are another phasic therapy that may be applied to thepatient based on the sensed myocardial activity or hemodynamics. Thepatient may be ventilated manually or by a mechanical ventilator. Theventilation may be synchronized with chest compressions or otherresuscitative therapies in conditions such as shock or pseudo-PEA.

The compressive force may be applied using a variety of devices orequipment. Some examples include mechanical chest compression devices,inflatable vests, nerve stimulators, abdominal compression devices,chest or abdominal active decompression devices, limb phasic compressiondevices, and the like. Further, the compressive force may be applied atdifferent locations on the chest, abdomen, limbs, or back, such as theleft lateral chest, cardiac point of maximal impulse and the like.

The myocardial activity may be sensed using a variety of sensingsystems. Such systems may include electrocardiography, Dopplerultrasonography, plethysmography, phonocardiography, echocardiography,transthoracic impedance and the like. These may be incorporated into aprobe that is coupled to the chest, abdomen, back, extremities, or acombination of these, or placed within the body, such as within theesophagus, trachea, or stomach. These various types of sensors maydetect myocardial activity by detecting, for example, cardiac electricalactivity, contractions, other movements of the heart, and palpablepulses of arteries. These measurements may be made from standardlocations such as the precordium, but also from the esophagus, trachea,or abdomen. Variations in the skin indicative of pulsating blood flow,and the rhythm and chemical content of the breath, may also be utilized.

The sensors and algorithms optimally suited to sense myocardial activitymay depend on characteristics of a particular patient. Further, thesensors optimally suited to sense myocardial activity may change duringthe course of treating. To determine the optimal sensor or sensors thatbest indicate myocardial activity, the system may include algorithms tovalidate the sensor(s) and to correlate sensor output data to a desiredpatient response, such as improved cardiac output. To validate thesensors, the system may apply or prompt the application of therapiessuch as chest compressions at a predetermined rate, force or vector andcompare the outputs of the sensors to expected sensor outputs orotherwise determine which sensor(s) generate signals that mostaccurately indicate the response of the patient to the predeterminedchest compressions. The validation of sensors results in anidentification of sensors and arrangements of sensors that generatesignals that most accurately measure or predict the response of thepatient. The sensors may be validated at the initiation of therapy andmay be revalidated periodically during treatment of the patient, such asat regular intervals or when a substantial change, e.g., beyond athreshold amount, occurs in the response of the patient to treatment.

The validated sensors or validated arrangement of sensors are thosesensors that have been determined to most accurately measure or predicta predetermined response(s) of the patient. Once the sensors have beenvalidated, signals generated only by the sensors, or pattern of sensors,identified in the validation process are used to provide feedback to thealgorithms that determine the application of phasic therapies such achest compressions and ventilation. Using these signals, the algorithmsmay generate and adjust a regimen for chest compressions andventilations of the patients. The regimen may dictate the force to beapplied by the chest compressions, the frequency of the chestcompressions, the shape and duration of the force applied by the chestcompressions, the synchronization and phasing of the chest compressionswith sensed myocardial activity, the location on the chest or other bodylocation, e.g., legs, of compressions, and a vector of the chest orother compressions. The algorithms may vary the regimen to optimize acondition of the patient, such as to increase sensed cardiac output.

In some cases, chest compressions may be performed manually, such asusing traditional CPR techniques. In such cases, an audio or visualsignal may be produced to indicate when the ejection phase is sensed.The generated signals may indicate to a rescuer when to apply the chestcompressions, whether to apply more or less force during thecompressions, or whether to apply the compressions to a differentlocation on the chest. In this way, the rescuer will be prompted as towhen, how and where to apply the compressive force to the patient. Thetone, volume, or other parameter, of the synchronizing prompt may bevaried so as to assist the rescuer in providing optimal CPR. In somecases, the chest, abdomen, or extremities may also be actively orpassively compressed or decompressed in an alternating manner with chestcompressions, and in synchronization with either cardiac ejection orfilling.

A system is disclosed here for improving the cardiac output andprognosis of a patient who is suffering from impaired myocardialmechanical states such as pulseless electrical activity or shock buthaving residual myocardial wall motion. The system comprises amyocardial activity sensor that is adapted to sense movement of themyocardial wall and or myocardial valvular motion to determine thepresence of residual ventricular contract and relaxation, and/or pumpfunction having an ejection phase and a filling phase. The system mayalso include a compression device that is configured to repeatedly applya compressive force to the heart, either through the chest wall,intrathoracically through the pericardium, or directly to the myocardiumthrough an endoscope and pericardial window. Further, a controller isemployed to receive signals from the myocardial activity sensor and tocontrol operation of the compression device such that the compressiondevice repeatedly applies a compressive force to the heart such that thecompressive force is applied during at least some of the ejection phasesand is ceased during at least some of the relaxation phases to permitresidual cardiac filling, thereby enhancing cardiac output and organperfusion.

As an option to using a mechanical compression device or as an initialtreatment applied before the compression device is setup on a patient,chest compressions may be performed manually. In such cases, the systemmay include a cadence device that is configured to produce audio and/orvisual signals indicative of when compressive forces are to be appliedand ceased. This same cadence system may be utilized to synchronizationother therapies phasic therapies such as ventilation or abdominalcounterpulsation.

The myocardial activity sensors that may be used includeelectrocardiography sensors, Doppler ultrasonography sensors,plethysmography sensors, phonocardiography sensors, echocardiographysensors, transthoracic impedance sensors, magnetic resonance imaging,and radiographic fluoroscopy. These sensors may be placed on thepatient's chest, abdomen, back or extremities, within body cavities suchas the esophagus, or some distance from the patient in the case oftechnologies like radiography or magnetic resonance imaging. If thepatient has an arterial pressure catheter in place, the controller mayalso utilize that signal for synchronization. Further, the controllermay be configured to apply the compressive force during each sensedejection phase or during only at certain ejection phases. As anotheroption, the controller may be configured to apply the compressive forcefor only a certain duration of the ejection phase.

The system may further include a ventilator device that is configured toprovide ventilation to the patient based on the sensed residualmyocardial mechanical activity. The controller may also vary the patternof individual ventilations so as to optimize synchronization.

A sensor may detect the expansion and relaxation of the chest due toventilation or chest compressions. The sensor may be a plastic adhesivestrip applied to the chest that stretches and contracts with themovement of the chest due. The stretch and contraction of the adhesivestrip may be detected as a change in an electrical property, e.g.,resistance, of the strip, optically due to a change in transmissivity orreflection of the strip or by other means. The stretch and contractionof the adhesive strip causes the adhesive strip sensor to generatesignals indicative of the expansion and relaxation of the chest. Thesesignals may be used by the algorithms to predict when blood is beingdrawn into the heart as the chest relaxes (expands) or when blood isbeing forced from the heart as the chest is compressed.

The phasic device may be a mechanical compression device, an inflatablevest, a nerve stimulator, or the like. Further, the system may include alifting device that is configured to actively decompress the chestduring the relaxation phase, or compress the abdomen during chestdecompression.

In another embodiment, a logic circuit may be used to vary the phasictherapeutic device or devices such that the optimal pattern andcombination can be determined and applied. This pattern may be variableover time and the invention will monitor for the possibility byoccasionally varying the pattern of therapies and adjusting according toan indicator of hemodynamics or predictor of outcome.

During resuscitation of patients suffering cardiac arrest, the presenceand degree of residual left ventricular mechanical (physical) activitymay vary over time. The system may be configured to detect transientperiods of left ventricular mechanical activity and to synchronizetherapies only during these periods to assist residual cardiacmechanical activity and achieve a greater cardiac output.

The sensor functions may be utilized to determine the vector of leftventricular ejection and to optimize the force vector of chestcompression spatially. This might be done utilizing an array of Dopplerprobes placed over the chest to detect the velocity of residualmyocardial motion from multiple locations and calculate the vector ofthat motion.

The vector of left ventricular blood flow ejection is generally from thepoint of maximal impulse in the left lateral chest between 4th and 6thintercostal spaces near the lateral clavicular line toward the medialcephalad direction. The system disclosed here can determine the vectorand align the force of chest compression with the vector to assistejection of blood and minimize interference with ventricular filling.

Utilizing an indicator of cardiac output, such as exhaled end-tidalcarbon dioxide or vital organ oxymetry, the controller circuit couldapply synchronized therapies during progressive shock and determine ifthey benefit the patient through increased blood flow.

A system is disclosed here to treat a patient having a heart and achest, the system comprising: a least one sensor monitoring cardiacactivity in the patient by detecting at least one of myocardial pumpactivity, myocardial mechanical activity, hemodynamics and organperfusion; a logic controller receiving signals from the at least onesensor and generating control commands for controlling one or morephasic therapies and synchronizing the one or more phasic therapies withthe monitored cardiac activity in the patient; and wherein the logiccontroller executes an algorithm stored in memory associated with thelogic controller, wherein the algorithm causes the logic controller togenerate commands to vary patterns of the application of the one or morephasic therapies, and thereafter detect changes in at least one of thesensed myocardial pump activity, myocardial mechanical activity,hemodynamics and organ perfusion due to variations in the patterns, anddetermine one of the patterns of phasic therapies corresponding to adesired level of at least one of sensed myocardial pump activity,myocardial mechanical activity, hemodynamics and organ perfusionhemodynamics and organ perfusion.

A method is disclosed here to treat a patient in shock comprising:sensing myocardial motion or pulsatile blood flow in the patient;repeatedly applying a phasic therapy to the patient synchronized to thesensed actual myocardial motion or pulsatile blood flow, wherein thephasic therapy includes repeatedly applying a compressive force to thechest or an electrical shock to the heart of the patient, and adjustingthe compressive force or electrical shock depending on whether the forceor shock coincides with a heart beat as indicated by sensed myocardialmotion or pulsatile blood flow.

A system is disclosed here to treat a patient having a heart and achest, the system comprising: a least one sensor monitoring cardiacactivity in the patient by detecting at least one of myocardial pumpactivity, myocardial mechanical activity, hemodynamics and organperfusion; a logic controller receiving signals from the at least onesensor and generating control commands for controlling one or morephasic therapies and synchronizing the one or more phasic therapies withthe monitored cardiac activity in the patient; and wherein the logiccontroller executes an algorithm stored in memory associated with thelogic controller, wherein the algorithm causes the logic controller togenerate commands to vary patterns of one or more phasic therapies, andthereafter detect changes in at least one of the sensed parameters dueto variation in the pattern of phasic therapies. The logic circuit wouldthen determine which one of the patterns of phasic therapiescorresponding to a desired level of at least one of sensed myocardialpump activity, myocardial mechanical activity, hemodynamics and organperfusion hemodynamics and organ perfusion.

A method is disclosed here to treat a patient comprising: sensing anatural rate of myocardial activity of the heart of the patient, andrepeatedly applying a phasic therapy to the patient synchronized to thesensed myocardial activity, wherein the phasic therapy includes repeatedmyocardial electrical stimulation applied at a rate faster than thesensed natural rate of myocardial activity. The method may furthercomprise a sensing system comparing at least one of the sensedmyocardial pump activity, myocardial mechanical activity, hemodynamicsand organ perfusion hemodynamics and organ perfusion with and withoutapplication of the phasic therapies to determine which of the phasictherapies optimally augments hemodynamics or perfusion.

A method is disclosed here to treat a patient having a heart and achest, the system comprising: monitoring cardiac activity in the patientby detecting with at least one sensor at least one of myocardial pumpactivity, myocardial mechanical activity, hemodynamics and organperfusion; receiving the signals from the at least one sensor and, basedon the signals, synchronizing one or more phasic therapies applied tothe patient to the monitored cardiac activity in the patient; varyingthe one or more phasic therapies; detect changes in at least one of thesensed myocardial pump activity, myocardial mechanical activity,hemodynamics and organ perfusion due to the variations in the one ormore phasic therapies; determine one of the variations of the phasictherapies corresponding to a desired level of at least one of sensedmyocardial pump activity, myocardial mechanical activity, hemodynamicsand organ perfusion hemodynamics and organ perfusion.

The method may further comprise comparing at least one of the sensedmyocardial pump activity, myocardial mechanical activity, hemodynamicsand organ perfusion with and without application of the phasic therapiesto determine which of the phasic therapies optimally augmentshemodynamics or perfusion.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of a system that may be used to improve thecardiac output of a patient according to the invention.

FIG. 2 is a schematic diagram of a controller that may be used toactuate a compression device based on signals from a myocardial activitysensor according to the invention.

FIG. 3 is a graph illustrating exemplary times for applying compressiveforces according to the invention.

FIG. 4 is a flow chart illustrating one method for improving the cardiacoutput of a patient according to the invention.

FIG. 5 is a flow chart illustrating a method to validate sensors used todetect myocardial motion and other patient parameters.

FIGS. 6A and 6B are a flow chart of an exemplary algorithm to determinewhen to initiate chest compressions and optimize a chest compressionregimen that may be combined with ventilation of the patient andelectrical stimulation of the heart.

FIG. 7A is a chart illustrating chest compressions of varying forceapplied in synchronization with a slow heart beat.

FIG. 7B is a chart illustrating a method to correct a synchronizationerror between chest compressions and a heart beat.

FIG. 8 is a chart illustrating a method to synchronize a chestcompression to a heart beat.

FIG. 9 is a chart illustrating a method to synchronize electricalcardiac stimulation to pulsatile flow or mechanical myocardial activity.

DETAILED DESCRIPTION

The invention relates to techniques and devices that may be used toincrease cardiac output for patients suffering from a wide variety ofailments ranging from shock to pulseless electrical activity (PEA) wherethe patient appears to be lifeless yet has some residual mechanicalheart activity. One exemplary technique of the invention is to sensewhen the heart is beating and then synchronize chest compressions, orother resuscitative techniques, with movement of the myocardial wall. Inthis way, various techniques may be used to optimally synchronize chestcompressions (or other elements of CPR) with residual left ventricularfunction to improve the outcome of such patients. Hence, the inventionmay be used to synchronize the compression force of external devices, onor around the chest, with the ejection phase of the residual leftventricular function, and the relaxation phase with residual cardiacfilling. In another aspect, the system and method disclosed hereinprovides various techniques and devices for sensing residual mechanicalfunction, and then turn this information into a useful data stream thatmay be used to operate the various components of resuscitativetechnology, including adjuncts to blood flow, ventilation, and cardiacstimulating technology.

Such techniques may be used with patients suffering from a wide range ofailments. One exemplary use is for patients who are believed to be incardiac arrest with pulseless electrical activity (PEA) andnon-detectable blood pressures, but who still have residual leftventricular function to some degree. However, it will be appreciatedthat the invention is not intended to be limited to only such a use, butto a wide range of conditions where there is some organized electrical(but impaired) mechanical cardiac activity.

For example, at one end of such a spectrum is normal spontaneouscirculation, where the cardiac outputs are normal and left ventricularmechanical and pumping function are normal. Below that level ishypotension then compensated shock. In such cases, the blood pressureand the patient's pulse are still palpable and there may be good cardiacoutput. However, for various reasons, the cardiac output is unable tomeet the metabolic demands of the body and homeostasis is at risk. Thisis evident by parameters such as decreasing urine output and increasingserum lactate, which are markers of inadequate organ function.

Below compensated shock is the state of uncompensated shock. This is astate in which the myocardium and the cardiovascular system are nolonger able to provide adequate amounts of blood flow, oxygen andnutrients to meet the needs of vital organs, and the function of thoseorgans is affected to the extent that they are beginning to becomedamaged. Blood pressures in this state might be, for example, 70/30 mmHg. systolic over diastolic. Also, urine output may cease, and thepatient may become confused because of inadequate cerebral function.Importantly, as shock progresses, the pathways to multi-organ systemfailure are initiated.

Below classical uncompensated shock is what might be called “extremeshock” which borders on cardiac arrest. In this case, the patientexhibits some residual myocardial function including some leftventricular ejection, but cardiac output is wholly inadequate to meetthe needs of vital organs. For example, cardiac output might be lessthan 1 liter per minute, blood pressure might be 50/20, urine output maybe minimal or absent, and the patient may be stuporous or comatose.Further, the patient may appear to be near death with significantlyimpaired cerebral function and stupor bordering on coma. If untreated,extreme shock will result in true cardiac arrest in a timeframe ofminutes. Generally, it is not possible to palpate arterial pulsesmanually in this range, and such patients may be classified as PEA byclinical personnel even thought their heart continues to beat.

Below the state of extreme shock is pulseless electrical activity (PEA)cardiac arrest, which importantly also has a spectrum of conditions anda range of hemodynamics. For example, at its upper end, PEA has bothleft ventricular mechanical function and cardiac output, but notsufficient enough to be detected as a peripheral radial or femoralpulse. If an intra-arterial catheter is placed into the patient, theblood pressure might be only 45/25, with blood pressure measurable onlyin major arteries of the chest, neck or groin. A Doppler probe placedover the neck or groin may detect forward blood flow. Blood flow is soprofoundly inadequate that the patient will generally appear lifelessand their pupils may dilate and become fixed. Further, they appear to bein cardiac arrest despite the presence of residual pump function andforward flow. The high end of PEA dynamics overlaps the low end of“extreme shock.” In such cases, the clinical personnel may not be ableto distinguish the differences. The electrocardiogram, while showingorganized electrical activity, is variable in its pathology and may berelatively normal in its QRS configuration. The inventor has termedelectromechanical dissociation (EMD) with residual myocardial mechanicalactivity “pseudo-EMD.”

Below the “high end” stage of PEA is electromechanical dissociation withalmost absent left ventricular function. The blood pressure measured byintravascular catheters just above the aortic valve will show aorticpulsations but the blood pressures measured are on the order of 25/15 mmHG, and there will be almost no associated forward blood flow. Withoutapplication of CPR, oxygen delivered to the vital organs will beessentially absent and irreparable injury to organs such as the brainoccurs within minutes. The electrocardiogram rarely has a normalappearing QRS configuration, and the overall pattern of the ECG may beslurred out and irregular.

The final stage of PEA is an organized electrical rhythm but no leftventricular mechanical function. This is true cardiac arrest. A cathetermeasuring pressures above the aortic valve will detect no pressure pulseand echocardiography will show no cardiac movement. Further, the cardiacoutput is 0 and the patient is in complete global ischemia and cardiacarrest. Without application of CPR, oxygen delivered to the vital organswill be 0, and irreparable injury to organs such as the brain occurswithin minutes. The overall pattern of the ECG is invariably slurred outand irregular.

Along the spectrum described above, the invention may be used in allcases where there is some myocardial mechanical activity andsynchronized resuscitative therapies may improve cardiac output. In suchcases, the invention may be used to detect residual mechanical activityand to synchronize such activity of the heart with resuscitationtechniques, such as those used in CPR (including chestcompressions/decompressions and/or ventilation). Hence, the inventionmay be utilized in any pathophysiologic state from true cardiac arrest,to pseudo-EMD PEA, through the various stages of shock, or in anyhemodynamics state in which residual myocardial mechanical function withand without cardiac output exists. By synchronizing chest compressionsand/or decompressions, among other potentially cyclical therapies, bothejection and filling phases of the cardiac cycle may be augmented. In sodoing, cardiac output and organ profusion may be increased, therebyimproving the outcome of patients with impaired hemodynamics.

As one particularly important example, one clinical situation that oftenoccurs and is challenging for physicians, is when patients progress fromshock to apparent PEA cardiac arrest. In the earlier stages of thisprocess, physicians tend to treat such patients with intravenousmedications and possibly controlled ventilation. While drugs such asantibiotics may be administered to patients in states such as septicshock, pressor drugs such as dopamine continue to be a mainstay oftreatment. Pressors, however, have generally not been shown to improvethe outcome of such patients despite raising the blood pressure. Thismay be because they improve blood pressure but also raise vital organoxygen utilization, such that the overall balance between oxygen supplyand demand is not improved. Pressor drugs also have significant directvital organ toxicity.

If, however, these parenteral therapies do not stabilize the patient,their shock may progress inexorably towards more and more extreme statesand eventually become cardiac arrest. Many practitioners in emergencymedicine and critical care continue to be unsure—and the medicalliterature remains unclear—as to which point a patient whose bloodpressure is dropping should begin to receive chest compressions. Indeed,physicians generally do not apply techniques such as external chestcompress before subjective loss of vital signs. This is because CPR, andin particular chest compressions, can interfere with cardiac functionand in particular cardiac filling if applied in an unsynchronizedmanner. For instance, a patient whose blood pressure is 60/40 who beginsto receive chest compressions out of synchronization with heart functioncould rapidly progress into full cardiac arrest. More specifically, inperforming CPR without synchronization, application of the compressionphase when the left ventricle is trying to fill may significantlydecrease cardiac output on the next ejection secondary to the FrankStarling Law of the heart. Hence, by detecting myocardial mechanicalfunction, chest compressions can be synchronized with the ejection phaseso that patients in shock may be treated without exacerbating theircondition and possibly moving them toward cardiac arrest.

Hence, the issue as to when chest compressions should begin when apatient is progressing through the stages of shock may be addressed bysynchronizing chest compressions, and possibly other mechanicaladjuncts, with the ejection and relaxation phases, so that the clinicianmay be more confident that chest compressions are assisting and notinterfering with residual circulatory function. In this way, theclinician does not need to be as concerned with the question as to whento begin chest compressions. In this manner, the invention may act toallow use of external mechanical adjuncts in the treatment of any formof shock in a manner similar to the methods by which intra-aorticballoon counterpulsation has been applied in cardiogenic shock. Theinvention may thus allow application of such adjuncts in thepre-hospital, and Emergency Department environments.

Another advantage of using synchronization is that it may be performedas an adjunct to therapies directed at the cause of the shock, such asantibiotics or thrombolysis, enhancing vital organ perfusion while thesetherapies are being administered. Indeed, improved hemodynamics may notonly stave off organ injury, it may improve the efficacy of parenteraltherapies. Further, synchronized chest compressions are unlikely to havesignificant organ toxicity, unlike pressor drugs.

As described above, one particular application of the invention is inconnection with those suffering from pulseless electrical activity(PEA). PEA is one of the three broad-types of cardiac arrest, the othertwo being ventricular fibrillation and asystole. PEA is also referred toas electromechanical disassociation (EMD). PEA has been described as“the presence of organized electrical activity on the electrocardiogrambut without palpable pulses.” Rosen P, Baker F J, Barkin R M, Braen G R,Dailey R H, Levy R C. Emergency Medicine Concepts and Clinical Practice.2nd ed. St Louis: C V Mosby, 1988. Unlike ventricular fibrillation,which can be specifically reversed with electrical countershock, PEAdoes not have a specific countermeasure. This may explain thetraditionally worse outcome of patients in PEA compared to ventricularfibrillation. Unfortunately, the incidence of PEA is increasing,possible because early risk modification is changing the natural historyof cardiovascular disease. It is now reported by some authorities thatthe majority of patients in cardiac arrest are in PEA at the time of EMSarrival. Additionally, a significant fraction of patients that areshocked out of ventricular fibrillation, or resuscitated from asystole,will experience PEA at some point during their resuscitation. Thecombination of these circumstances mean that a large majority ofpatients receiving advanced life support for treatment of cardiac arrestwill have PEA at some time during resuscitation. Hence, now or in thenear future PEA may supersede classical ventricular fibrillation inimportance. It may already have done so.

Many patients with PEA have residual cardiac mechanical activity, andmany have detectable blood pressures. This condition may be referred toas pseudo-EMD PEA. In such cases, the patient may appear lifeless andwithout a pulse. However, there often remains some degree of residualleft ventricular function. Hence, one important feature of the inventionis to sense when the patient still has some myocardial function and thento synchronize phasic resuscitation therapies, especially compression ofthe chest, with the heart's residual mechanical function. In this way,the compression phase of CPR may occur during the ejection phase, andthe relaxation phase can allow elastic recoil of the chest—withassociated decreases in intrathoracic pressure when the left ventricleis trying to fill. In this way, synchronizing phasic resuscitativetherapies with residual ventricular ejection and filling, may improvehemodynamics, the rate of a return to spontaneous circulation (ROSC),and long term survival.

The invention may incorporate various non-invasive sensing technologies(represented by sensor 12 in FIG. 1) to acquire real-time datadescribing the pattern of myocardial wall and or valve motion so as toallow synchronization of chest compressions and other therapies. If,however, invasive indicators of hemodynamics, such as intra-arterialpressure or flow monitors, are present, then the invention may act as aninterface between those inputs and phasic resuscitative therapies asexemplifies by external chest compression. To apply propersynchronization between the forces of external devices, on or around thechest or body, and the ejection and filling phases of residual leftventricular function, a variety of devices may be used. The decisionthat residual myocardial activity exists may be made from a logiccircuit with inputs from multiple sensing modalities. The invention mayutilize sensing technology to collect the data on myocardial wallfunction, myocardial valve motion, blood flow in vascular structures,vital organ oxygen or energy status, or exhaled pulmonary gas, and thisdata may be passed through logic circuits and a controlling outputsignal passed to the devices that deliver therapies. Because the patternof mechanical residual wall function may be variable over time, theinvention may be designed to promptly identify residual function and tovary therapeutics based on feed back to a logic circuit. Also, thesynchronizing of external chest compressions may be used with othertechniques, such as with abdominal counter pulsations, phasic limbcompression, ventilation, and electrical stimulation, among others, toaugment cardiac ejection and filling. In this way, the patient may bestabilized to allow sufficient time for primary therapies, such asthrombolysis, to be effective.

A wide variety of equipment and device may be used to provide chestcompressions. For example, various types of automated compressionsystems may be use to compress the chest. These include systems, such asthe AutoPulse Resuscitation System, by ZOLL Circulation, Inc. ofSunnyvale, Calif., the Thumper manufactured by Michigan Instruments orthe LUCAS device, and the like. Further, the invention is not limited toautomated compression systems, but may be used with manual techniques aswell. For example, the invention may be used to provide an audio and/orvisual signal to indicate to a rescuer as to when to manually applychest compressions. Further, in some cases a suction device may beadhered to the chest so that the chest may be actively liftedintermittently with chest compressions.

Using either manual or automated equipment, the invention may beconfigured to synchronize external chest compressions with any residualmechanical activity of the myocardium such that when the myocardiumenters pumping or systole phase, CPR is in the chest compression phase.Further, when the heart enters its refilling or diastole phase, chestcompressions enter the relaxation phase. Sensory data may be passedthrough a logic circuit and outputs of that circuit used to control whenduring cardiac ejection or filling of synchronization occurs. Theserelationships may be varied over time to optimize the efficacy.

In addition to synchronizing chest compressions with residual heartfunction, the invention may also be use to synchronize ventilations withresidual heart function. For example, inspiration and expiration may besynchronized with residual myocardial function so as to increase cardiacoutput. For instance, inspiration may be synchronized to systole andexpiration with diastole. To apply ventilations, the invention may use atraditional ventilator or ventilations may be provided manually, such asby using a ventilatory bag. In the latter case, an audio and/or visualsignal may be provided to the rescuer as to when to apply properventilations.

With both chest compressions and ventilations, the timing, frequencyand/or duration may be varied depending on the particular treatment. Forexample, chest compressions may occur during the entire systole phase,or only during a portion of it. Further, chest compressions may occurevery systole phase or during only certain systole phases. A similarscenario may occur with ventilations. The controller may use one or moresensory inputs, and a logic circuit utilizing and indicator orindicators of efficacy, to optimize the effect of synchronization onhemodynamics.

The system disclosed herein may be utilized with any therapy that maybenefit from synchronization with residual myocardial mechanicalfunction in apparently lifeless patients. Chest compression anddecompression, abdominal counter-pulsation, ventilation, phasiclimb-compression, myocardial electrical stimulation, intravascular fluidshifting, intravascular or intra-pericardial ballooninflation-deflation, application of transthoracic electromagneticirradiation, among others. The controller logic circuit may vary thepattern of synchronization among multiple therapies so as to determinethe optimal pattern with respect to increasing hemodynamics.

Myocardial electrical stimulation is, for example, external electricalshocks delivered through metal paddles or electrodes applied to thechest, or electrical signals applied directly to the heart from aninternal pacemaker modified to synchronize myocardial electricalstimulations to, for example, myocardial wall function or detectedpulsatile blood flow.

To sense myocardial wall function, a variety of noninvasive devices andtechnologies may be used. For example, one technology that may be usedis electrocardiography (ECG). ECG may be an attractive detection methodbecause it is already used in most clinical situations duringresuscitation. However, because myocardial activity is not alwayspresent with ECG during PEA, it may need to be used in combination withother sensing techniques as described below. Another example of asensing technique that may be used is Doppler ultrasonography (DOP).Doppler ultrasound uses the Doppler shift of ultrasonic wave to quantifythe blood flow in peripheral vessels. This may be applied with atransducer on the neck for carotid flow, the groin for femoral flow, ora transthoracic or intraesophageal transducer for aortic flow. A Dopplerprobe may also be placed at the cardiac point of maximum impulse todetect movement of blood within the myocardium. An array of Dopplerprobes may be used to determine the vector of residual myocardialmechanical function and align chest compression and relation with thatvector.

A dynamic pressure sensor detects pulsatile flow by sensing the oxygencontent in a peripheral vein. The oxygen content sensed by the ROSSsensors as blood pulses through the peripheral vein. Similarly a pulseoximetry sensor may also be used to detect the oxygen content in a bloodvessel in, for example, the toes, fingers or ear lobes. The oxygencontent of the blood may be used to determine when to initiate andterminate CPR and mechanical or electrical cardiac stimulation. Forexample, if the ROSS sensor or pulse oximetry sensor detects pulsatileflow and an oxygen content above a threshold, the system may reduce theforce of chest compressions or terminate chest compressions. Similarly,if the ROSS or oximetry sensor detects no pulsatile flow or an oxygenlevel falling below a threshold, the system may initiate manual chestcompressor or electrical cardiac stimulation. The system may adjustvarious parameters of phasic therapies based on trends in the sensedoxygen status.

The data regarding pulses in peripheral blood vessels may be utilized toestimate residual myocardial mechanical function, such as the cardiacejection phase, based on stored information regarding the delay betweenthe myocardial mechanical function and pulse pressure or pulsatile flowin the peripheral blood vessel.

A further sensing technique that may be used is plethysmography (PLETH).Plethysmography may be applied by measuring changes in the transthoracicAC electrical impedance with heart motion. A further technique that maybe used is phonocardiography (PHONO). Phonocardiography records theacoustical energy detected by a stethoscope over the heart. Still afurther technique that may be used is echocardiography (ECHO). Withechocardiography or ultrasound imaging of the heart, left ventricularejection can be quantified. In some cases, echocardiograph detection ofheart function may be combined with ECG. Also, sensitivity may beimproved through the use of intravenously injected microbubbles or otherultrasound enhancing technologies.

It may be optimal to combine a number of these detection systems so asto increase the sensitivity and specificity of detecting residualmyocardial mechanical function. Additionally, it may be optimal toincorporate a logic circuit which compares combinations of sensingtechnologies to an indicator of actual cardiac output, such as end-tidalcarbon dioxide or aortic flow. In this manner, the invention coulddetermine which combination of sensing technologies are most predictiveof improvements derived from synchronization.

Additionally, the logic circuit of the invention might be capable ofvarying the synchronized therapeutics against indicators of actualcardiac output so as to determine which pattern of synchronized therapyis most effective. It may vary synchronization within one therapeuticdevice or multiple therapeutic devices so as to identify the optimalpattern.

Referring now to FIG. 1, a system 10 for improving cardiac output willbe described. System 10 includes a sensor, or sensors, 12 that may beused to detect residual myocardial mechanical function. In oneembodiment, sensor 12 may comprise a surface probe that rests on thepatient's chest. Sensor 12 may be placed at a variety of locations onthe chest. For example, one location may be the anterior chest in one ofthe intercostal spaces. Another location may be the sub-xiphoid locationin the epigastrium. Sensor 12 may sense myocardial wall motion using anyof the technologies described herein, including ultrasound, Dopplertechnology, echocardiography, plethysmography and the like. As analternative to placing sensor 12 on the patient's chest, it will beappreciated that other locations may be used as well, such as a probethat is placed on the neck over the carotids, or into the patient'sesophagus. It will also be appreciated that sensor 12 may be an array ofsensors.

The sensor 12 may be a sensor or sensors for a variety of sensingsystems such as electrocardiography, Doppler ultrasonography,plethysmography, phonocardiography, echocardiography, transthoracicimpedance and the like. The sensor 12 may be incorporated into a probethat is coupled to the chest, abdomen, back, extremities, or acombination of these, or placed within the body, such as within theesophagus, trachea, or stomach. These various types of sensors detectmyocardial activity by detecting, for example, cardiac electricalactivity; physical contractions and other movements of the heart,palpable pulses of arteries in, for example, the esophagus, trachea, orstomach; variations in the skin indicative of pulsating blood flow andthe rhythm and chemical content of the breath.

The data collected by sensor 12 is transmitted to a controller 14 havingsignal processing and logic capabilities. A further description ofcontroller 14 will be described hereinafter with reference to FIG. 2.Controller 14 is also electronically coupled to a compression device 16that may be used to apply external chest compression to the patient. Insome embodiments, it will be appreciated that controller 14 could beincorporated into compression device 16 or into any of the sensors. Forease of use, both the sensor 12 and the controller 14 may beincorporated into the therapy device 16. Further, controller 14 could bewirelessly connected to the sensing and/or compression devices. In theexample illustrated in FIG. 1, chest compression device 16 includes aninterface member 18 that is coupled to a piston 20 which moves interfacemember 18 against the chest in a repeating manner. In this way, chestcompression device 16 may apply repeating chest compressions to thepatient. In some cases, interface member 18 may be configured to adhereto the patient's chest so that as piston 20 lifts interface member 18,the patients' chest will also be lifted. In this way, chest compressiondevice 16 may apply alternating chest compressions and decompressions.Although described in the context of chest compression device 16, itwill be appreciated that a wide variety of equipment may be used toapply chest, abdomen or extremity compressions and/or decompressions inan automated manner as described herein, and that the invention is notintended to be limited to only the specific embodiment of chestcompression device 16. For instance, examples of existing CPR equipmentthat may be modified to function in connection with controller 14include the AutoPulse Resuscitation System by Revivant of Sunnyvale,Calif., or the Thumper manufactured by Michigan Instruments. As anotheroption, an inflatable vest 21 may be coupled to controller 14 and beconfigured to be inflated and deflated to perform propersynchronization.

As an alternative to applying automated chest compressions, theinvention may also be used with manual techniques. In such cases,controller 14 may include a speaker 22 and/or a light 24 that provideinformation to a rescuer as to when to apply chest compressions and/ordecompressions. For example, speaker 22 may be configured as a metronometo apply a repeating signal, or could give instructions in a humanunderstandable voice. Light 24 may be configured to repeatedly flash toindicate when to apply chest compressions and/or decompressions. It willalso be appreciated that a force transducer may be placed between thehands of the person providing manual chest compression and the patientssuch that the force, timing and vector of chest compression can besensed so that the accuracy of synchronization is evaluated.

Chest compressions may be applied at a variety of locations. Examplesinclude the sternal area, parasternal areas, circumferentially, theback, and the like. The abdomen may be compressed or counterpulsedbroadly or with specific emphasis on the areas of the abdominal aorta orinferior vena cava. The extremities may be compressed rhythmically. Thepattern of ventilation may be varied.

Controller 14 configured to receive data from sensor 12 and then processthe signals in order to operate chest compression device 16, speaker 22or light 24. More specifically, controller 14 is configured tosynchronize external chest compressions and/or decompressions with anyresidual mechanical activity of the myocardium sensed by sensor 12. Inthis way, when the myocardium enters the pumping or systole phase, chestcompression device 16 is configured to force interface member 18 againstthe chest to apply a chest compression. When the heart enters itsrefilling or diastole phase, controller 14 is configured to liftinterface member 18 so that no compressive forces are being applied tothe chest. It is understood that the therapeutic impulses may berestricted to a portion of each phase.

The vest 21 may include separately inflatable chambers 23 wherein eachchamber is coupled via a conduit 25 to an air pump 27. Valves 29 in theconduits are actuated by the controller 14 to cause the inflation anddeflation of the chamber associated with the valve. By selectivelyinflating and deflating the chambers, specific locations on the chestand back of the patient that are compressed can be to enhance the chestcompressions and increase the cardiac output. As an alternative to avest with chambers, the chest compression device may include a forceinterface member 18 that is segmented into a plurality of separatelyactuated pads 18 a, 18 b applied to compress the chest. Depending onwhich of the pads 18 a, 18 b are actuated to compress the chest and thesequence in with one or more of the pads are actuated the position onthe chest of the chest compressions and the vector of the force appliedby the chest compression can be varied to enhance, for example, cardiacoutput.

System 10 further includes a ventilation system 26 that is coupled tocontroller 14. For example, ventilation system 26 may comprise aventilator that is in fluid communication with a mask 28. Controller 14may be configured to synchronize inspiration and expiration to residualmyocardial function as detected by sensor 12. For example, ventilationsystem 26 may be configured to provide positive pressure ventilationsduring systole and allow for expiration during diastole, or vice versa.Controller 14 may also be configured to coordinate operation ofventilation system 26 with chest compression device 16. As an option tousing a mechanical ventilator, the invention may also utilize othertechniques, such as a ventilatory bag that may be mechanically squeezedby the patient. In such cases, speaker 22 or light 24 may be actuated toindicate to the rescuer as to when to apply proper ventilations.

Referring now to FIG. 2, one aspect of controller 14 will be describedin greater detail. As previously described, controller 14 receivessignals from sensor 12 regarding residual myocardial wall function.Typically, signals from sensor 12 will be in analog form. As such,controller 14 may include an amplifier and filter 30 which amplify andfilter the analog signal. Controller 14 also includes a peak or slopedetector 32 which is circuitry that detects either peaks or slopes ofthe analog signal that are indicative of myocardial wall motion.Detector 32 may be configured to trigger on rapid increases in signalamplitude. The triggered signal from detector 32 will pass through avariable time delay circuitry which is fed to a pulse generator 36 thatconverts the analog trigger into a digital pulse of fixed amplitude andduration. The variable time delay 32 may be added to this pulse to allowfor fine adjustment of synchronization in timing. The delayed pulse isthen processed as an output to chest compression device 16 in digitalformat.

The controller may combine inputs from a number of sensing systems so asto increase the sensitivity and specificity of detecting residualmyocardial mechanical function. Additionally, it may be optimal toincorporate a logic circuit, possibly within a microprocessor, whichcompares combinations of sensing technologies to an indicator of actualcardiac output, such as end-tidal carbon dioxide or aortic flow. In thismanner, the invention could determine which combination of sensingtechnologies are most predictive of improvements derived fromsynchronization. Additionally, the logic circuit of the invention mightbe capable of varying the synchronized therapeutics and comparing thecombinations to amount of residual myocardial synchronization andmeasured cardiac output so as to determine which pattern of synchronizedtherapy is most effective.

As previously mentioned, chest or abdominal compressions and/orventilations may be applied during different times of the cardiac cycleand may be varied over the cycles themselves. The arterial bloodpressure shown in FIG. 3 represents the pulsatile flow as indicated bythe increase in arterial blood pressure for each pulse 300. The dottedlines in FIG. 3 refer to an initial increase or predetermined change toan upward slope 302 in arterial blood pressure, a peak pressure 304 andan end of the pressure pulse, such as represented by a predeterminedchange to a downward slope of the pressure. For example, as illustratedin FIG. 3, a chest compression may be applied each time the sensordetects the ejection phase, and this compression may occur throughoutthe entire ejection phase as shown in A—Full Cycle portion of FIG. 3.Alternatively, the chest compression could be applied only during thefirst half of the ejection cycle as shown in B—1^(st) Half Cycle. Asanother option, the chest compression could be applied during the secondhalf of the ejection cycle as shown in C—2^(nd) Half Cycle. As a furtheralternative, chest compressions could be applied during each ejectioncycle, or only during certain ejection cycles, such as every second,third, or fourth ejection cycle. Also, the magnitude of chestcompressions may be evaluated to determine if they should be increasedor decreased throughout the procedure. A similar scenario may be usedfor chest decompressions, abdominal compression decompression orcounterpulsations, limb compressions, and the phases of ventilations.

In summary, by utilizing a sensor, or combination of sensors, anapparently lifeless patient's residual myocardial wall function may bedetected and the application of phasic resuscitative therapies,including chest compressions and/or decompressions as well as abdominalcounterpulsations, and ventilations may be precisely controlled so thatthe application of CPR components enhances, and does not interfere withthe existing mechanical activity of the heart. The device may alsopotentially be used in patients suffering severe shock with residualsigns of life.

Referring to FIG. 4, one exemplary method for treating a patientsuffering from ailments ranging from shock to PEA will be described.Initially, the patient is evaluated to determine if there is anymyocardial activity as illustrated in step 40. If myocardial activity isnot present, the rescuer may wish to consider other treatments asillustrated in step 42. For example, such treatments could include theuse of a defibrillating shock as is known in the art. If some myocardialwall activity is detected, the process proceeds to step 44 where thetiming of the ejection phase and filling phase is determined. Aspreviously described, this may be determined by the use of a sensor thatis used to sense myocardial wall activity. Also determined may be thevector and baseline oxygen or energy state of vital organs. Depending onthe amount of activity exhibited by the heart, a compressive force oranother phasic therapy may be applied to the heart during one or more ofthe ejection phases as illustrated in step 46. This may be accomplishedby using automated equipment or by using manual techniques. In eitherevent, the applied compressive forces may be synchronized with theejection phase so that the compressive forces do not interfere with therefilling phase. Optionally, as illustrated in step 48, the manner ofcompressions may be varied. This may include the time, duration, amount,frequency, vector, and the like. These variables may be initially setafter measuring the amount of myocardial wall activity and may bechanged or varied throughout the procedure depending on the patient'sphysiological condition.

As illustrated in step 50, the patient may periodically be provided withventilations. The phases of ventilations may also be synchronized withthe sensed ejection phases and refilling phases as measured in step 44.Further, the ventilations may be coordinated with the application of thechest compressions.

In some cases, the patient's chest may be actively lifted in analternating manner with chest compressions as illustrated in step 52. Insuch cases, the chest may be lifted during the filling phase as measuredin step 44.

As another optional step 54, the patient may periodically be providedwith medications as part of the treatment. Examples of medications thatmay be applied include epinephrine, vasopressin, amiodarone, and thelike. Alternative phasic therapies for use in step 46 may also besynchronized with residual myocardial activity. These other phasictherapies may include, among others: abdominal counterpulsation,ventilation, phasic limb-compression, myocardial electrical stimulation,intravascular fluid shifting, intravascular balloon inflation-deflation,application of transthoracic electromagnetic irradiation.

Throughout the procedure, the patient's heart may be continuallymonitored to determine myocardial activity as well as otherphysiological conditions. For example, after each of the treatments insteps 46, 48, 50, 52 and 54, the condition and response of the patientis monitored. Depending on the sensed response and condition, theselection and application of these treatments may be adjusted to achievea desired response and condition of the patient. Depending on thepatient's condition, any of the items discussed in steps 44-54 may bevaried or stopped over time. At step 56, the process ends.

FIG. 5 is a flow chart illustrating an exemplary process executed by thecontroller 14 to validate the sensors 12 shown in FIG. 1. The sensorvalidation process 500 may be embodied in an algorithm stored assoftware or firmware in electronic memory of the controller 14 andexecuted by a processor of the controller. The sensor validation process500 may include applying a predetermined regimen 502 chest compressionregimen, such as a regimen of one or more chest compressions ofpredetermined force(s), vector(s), frequency and location(s) on thechest. Each of the sensors generate and output signals to the controllerthat indicate a condition of the patient being sensed by each of thesensors.

The controller analyzes 504 the output signals to determine which of theoutput signals or group of signals best indicate the condition of thepatient, such as cardiac output. The algorithm 500 may compare theactual output signals to expected sensor output signals 506 stored inthe memory of the controller. Based on the comparison, the controlleridentifies 508 the sensor(s) generating signal(s) that accurately andclearly report the condition of the patient in response to the regimenof chest compression(s).

The sensors identified in step 510 are deemed to be best suited to sensemyocardial activity may depend on the particular patient and thecircumstances of the PEA condition. The sensor validation procedure 500may be performed at the initiation of chest compressions andperiodically thereafter, especially if myocardial output does notimprove in an expected manner.

Once the sensors have been validated, signals generated by the sensorsidentified in the validation process are used to provide feedback to thealgorithms, such as shown in FIGS. 4 and 6, that determine the chestcompressions and optionally synchronized ventilation and synchronizedelectrical stimulation of the heart. Using these signals, the algorithmsmay generate and adjust a regimen for chest compressions andventilations of the patients. The regimen may dictate the force to beapplied by the chest compressions, the frequency of the chestcompressions, the shape and duration of the force applied by the chestcompressions, the synchronization and phasing of the chest compressionswith sensed myocardial activity, the location on the chest or other bodylocation, e.g., legs, of compressions, and a vector of the chest orother compressions. The algorithms may vary the regimen to optimize acondition of the patient, such as to increase sensed actual cardiacoutput or actual hemodynamics, e.g., pulsatile blood flow.

FIGS. 6A and 6B are a flow chart of an exemplary algorithm 600 todetermine when to initiate chest compressions, synchronize the chestcompressions to cardiac activity and optimize the chest compressionregimen which may be combined with ventilation of the patient andexternal electrical stimulation of the heart. In step 602, sensorsapplied to a patient suffering from shock or other cardiac aliment aremonitored to detect cardiac electrical activity, e.g.,electrocardiography (ECG/EKG), and to detect directly myocardial motionor pulsatile blood flow.

The sensor signals from step 602 provide the controller and the healthcare provider with information from which to determine whether toinitiate chest compressions. For example, if the ECG signals indicate asteady, regular heart beat, the controller may determine that chestcompressions are not needed, in steps 604 and 606. The signals from step602 may be analyzed in step 604 to determine whether, for example, theECG signals do not indicate a regular or sufficiently frequent heartbeat. If the ECG signals indicate an irregular or infrequent heart beat,the controller may determine (604) that chest compressions are needed(606) to augment the remaining natural cardiac activity.

In addition, signals from the sensors detecting pulsatile blood flow andactual myocardial motion may be compared to the signals of cardiacelectrical activity to confirm that the cardiac electrical activity issynchronized with actual cardiac output. If the there is no detectablecardiac electrical activity or if the cardiac electrical activity isdisassociated with pulsatile or actual ejection of blood from the heart,the controller may rely on sensors detecting actual myocardial movementor pulsatile blood flow to monitor cardiac movement and output. Thecontroller may perform a sensor validation algorithm (FIG. 5) toidentify the sensors generating signals that accurately and clearlyindicate cardiac movement and output.

After chest compressions have been initiated (step 606), the controllerexecutes algorithms (FIG. 4) to synchronize (step 608) the chestcompressions to the sensed myocardial motion, e.g., to an EKG/ECG signalor to sensor signals indicative of pulsatile or actual myocardialmotion. While the chest compressions are applied, the controller relieson the validated sensors to provide feedback information regarding thecontraction or ejection phase of the heart and the cardiac output of theheart.

In step 610, the controller executes algorithms (see FIG. 4) to optimizethe chest compression regimen to enhance cardiac output. The chestcompression regimen may be optimized using the signals generated by thevalidated sensors that provide information regarding cardiac output oranother condition of the patient. The chest compression regimen may beoptimized by varying the parameters of the chest compressions, such asvarying the force and frequency of the compressions, the location of thecompressions on the chest or other location on the patient and the phaseof the synchronization between the compressions and thecontraction/ejection of the heart. To optimize, the controller may varyone or more of the parameters of the chest compressions and analyze theresponse to the varied parameter(s) generated by the validated sensors.

Examples of parameters of the chest compression that may be varied andoptimized include: the depth of the compressions made into the chest;the during of each compression, the velocity of each compression, theforce applied to the chest during each compression, the rate of thechest compression, the shape of the compression (such as the duration atthe depth of the compression), the location of the compression on thechest, and the phase of synchronization between the chest compressionand the sensed cardiac activity. While varying one or more of theseparameters, the response of the patient to the chest compression ismonitor and a determination is made at to which combination of parametersetting yields the most advantageous response, such as strongestarterial pulse flow.

In step 612, the controller synchronizes ventilation of the patient andelectrical stimulation of the heart to the chest compressions or tocontraction/ejection of the heart. The electrical stimulation may berepeated and coordinated with the chest compressions. In step 614, thesensors, e.g., validated sensors, detect or measure the response of thepatient to one or more of the compressions, ventilation and electricalstimulations. In step 616, a determination is made that the detected ormeasured response is achieving a desired result or outcome in thepatient. If a desired result or outcome is not being achieved, thecontroller may adjust the compressions, ventilation or electricalstimulations until the desired result or outcome is achieved.

FIG. 7A is a chart 700 illustrating chest compressions applied insynchronization with a slow heart beat. Patients suffering a cardiacarrhythmia may have a slow heartbeat 702, e.g., a heartbeat below 55 to60 beats per minute. The controller detects the heart beat from sensorsignals indicating pulsatile flow and determines that the heart beat isslow and sensors detecting aortic pressure that provide signalsindicating a weak heartbeat. To compensate for a slow or weak heartbeat,the controller generates commands 706, 708 to actuate a chestcompression device or audible and visible commands to notify when chestcompressions are to be applied and, optionally, to indicate a force tobe applied by the chest compressions.

The audible commands may include computer generated voice commands suchas, during the chest compressions, “press softer”, “press harder”,“press deeper”, “press shallower”, “press faster (or slower)” and “presslower (or higher) on the abdomen”. Similarly, visible commands may becomputer generated display images corresponding to these voice commands.The audible and visible commands may be the result of computer analysisof feedback signals generated from sensors monitoring the pulsatileflow, myocardial activity, breathing or other condition of the patient.

The force of the chest compressions to be applied is indicated by thelength of the dotted line 706, 708 shown in FIG. 7. The chestcompressions 708 that coincide with each heartbeat 704 may besynchronized with the ejection phase of the heartbeat. Chestcompressions may not be applied during the ejection phase and during theperiod during which the heart is susceptible to comodio cordius.Additional chest compressions 706 are applied during periods between thenatural heart beat. The force of these chest compressions 706 may besufficient to result in a cardiac output which approximates the desiredcardiac output 710. The level of force of the chest compressions that iscommanded by the controller may be varied based on feedback signals fromsensors detecting the cardiac output. Further the chest compressions 708that coincide with the heartbeat may be applied at a substantially lowerforce than the chest compressions 706 that are out-of-phase with thenatural heartbeat. The lower force of the chest compressions 706 areintended to augment the natural contraction of the heart to ejectionblood at a sufficient force to achieve a desired level of cardiacoutput. The controller estimates the lower level of force to be appliedby the chest compressions 708 (as indicated by the short dotted linesassociated with 708 on FIG. 8) and issues commands to the chestcompression device to apply a certain level of chest compressions. Thecontroller may also issue an alert to a health care provider to notapply a force to the chest during a period 712 coinciding with theheartbeat to avoid having chest compressions applied which counter actthe natural heartbeat 704.

FIG. 7B is a time line chart including a line 802 indicating a slowheart beat, a line 804 indicating chest compressions occurring morefrequently than the heart beat, a line 806 indicating a timer triggeringthe chest compression, and a line 808 indicating an error correctioncounter. As indicated by line 802, the heartbeat is naturally occurringonce every three (3) seconds, in this example. This slow heart beat maybe detected by its ECG electrical signal. Because the heartbeat is slow,chest compressions (see line 804) are applied more frequently, e.g.,every second, than the heart beat. The higher frequency of the chestcompressions may be a harmonic of the frequency of the heart beat. Aharmonic frequency should maintain synchronization between the chestcompressions and the natural heart beat.

The chest compressions are synchronized with the heart beat. In thisexample, every third chest compression 810 coincides with the heartbeat. It is desirable that the chest compression be synchronized withthe ejection phase of the heartbeat. For example, the start of the chestcompression should coincide with the QRS electrical signals 812 thatprecedes the ejection phase of the cardiac cycle.

A timer in the system that controls or triggers the chest compressionsgenerates a timing signal 806 that triggers the start 814 and end 816 ofeach chest compression. The timing signal 806 triggers chestcompressions at regular intervals, such as about every second. Theregular intervals of the chest compressions may, over time, becomeunsynchronized with the heart beat 802.

To maintain synchronization between the chest compressions and the heartbeat, a timer or counter generates an error signal 808. The timer is inthe system that controls or triggers the chest compressions. The errorsignal is used to measure the period between the QRS signal 812 and thechest compression 810, e.g., the initiation of the chest compression,nearest the QRS signal. If the QRS signal 812 and the chest compressionare synchronized, an error period 818 may be instantaneous or brief asshown by the error signal 808. A longer error signal 820 results if theinitiation of the chest compression does not occur at about the sametime as the QRS signal. As an alternative to the QRS signal, the errorperiod 818, 820 may be determined based on sensed pulsatile flow orsensed mechanical myocardial activity.

The error period is triggered by the chest compression timing signal 806and particularly by the signal 814 initiating the chest compression. Theerror period 820 may be a positive period if the chest compressionstarts 814 before the QRS period. A positive error period is applied bythe system to delay the next chest compression by the duration of theperiod. The delay should cause the chest compression that coincides withthe next heart beat to by synchronized with that heart beat. Similarly,the error period 820 may be a negative period if the QRS signal precedesthe chest compression signal. A negative error period 820 may be appliedto advance the occurrence of the next chest compression by the durationof the negative error period. The advance should cause the chestcompression that coincides with the next heart beat to be synchronizedwith the heart beat.

The determination of the error period is similar to a phase lock loopcontrol technique conventionally used in control systems. The delay oradvance due to an error period 820 to the chest compression signal 814may occur entirely in a period between two chest compressions, or may bedistributed evenly between two or more periods depending on the lengthof the delay or advance. Similarly, the error period 820 may not resultin a delay or advance if the period is shorter than a thresholdduration, e.g., 10 milliseconds.

FIG. 8 is a chart illustrating a method to synchronize chestcompressions 902 to a heart beat shown by line 904. The electricalsignals of a heart beat conventionally include a P-wave, the QRS waves,and the T wave. It is well known that the P-wave indicates atrialelectrical activation (depolarization), the QRS wave complex indicates arapid depolarization of the ventricles and the start of the cardiacejection phase, and the T wave indicates the recovery (repolarization)of the ventricles. The chest compression 902 optimally occurs during theejection phase immediately following the QRS wave.

The chest compression is terminated 906 before a safety period 908before the T wave. The period may be a short duration such as 10 to 200milliseconds. The safety period 908 is applied to ensure that the chestcompression does not continue to the T wave particularly during theportion 910 of the T wave during which the heart is vulnerable tocommotio cordis, which is a disruption of the heart rhythm due to a blowto the heart during the T wave.

FIG. 9 is a chart illustrating a method to synchronize electricalcardiac stimulation 1002 to aortic pressure (AoP) pulses 1004 due tomyocardial mechanical activity. The aortic pressure (AoP) pulses may bedetected based on ECG signals, pulsatile flow and myocardial activity.If the heart is producing ECG signals that are synchronized with themyocardial mechanical activity, the QRS signal 1006 of the ECG may beapplied to trigger each electrical cardiac stimulation pulse 1008.Alternatively, the electrical stimulation pulses 1008 may be triggerbased on pulsatile flow or sensed myocardial mechanical activity.

The electrical stimulation pulses 1008 may be applied at a frequencygreater than the natural heat beat, such as in the manner shown anddescribed in connection with FIG. 7B. Further, the frequency and timingof the electrical stimulation pulses may be adjusted in the manner shownand described in connection with FIG. 8.

The electrical pulse signals 1008 may be applied to the chest of thepatient or directly to the heart for each heart beat. The electricalsignal is applied for each heart beat to assist the heart in restoringnatural electrical stimulation, to resynchronize the natural electricalstimulation to the myocardial mechanical activity or to supplement thenatural electrical stimulation to increase the ejection force from themyocardial mechanical activity.

The electrical pulse signals may be a “pacer pulse” such as thatdelivered by a conventional pacemaker and having a value of less than500 milliamps (mA). Alternatively, the electrical pulse signals mayshock the heart by delivering a pulse of between 500 mA to 5 A, which issimilar to a low energy defibrillator pulse.

The application of the electrical pulse signals for each heart beat isin contrast to a conventional pacemaker device that does not issue anelectrical stimulation for each heart beat. A conventional pacemakerissues an electrical stimulation one if and when a timer expires withoutthe occurrence of a natural heart beat. A conventional pacemaker issuesan electrical signal when a natural heartbeat does not occur in aprescribed period and does not issue an electrical signal that issynchronized with a naturally heartbeat.

The invention has now been described in detail for purposes of clarityand understanding. However, it will be appreciated that certain changesand modifications may be practiced within the scope of the appendedclaims.

What is claimed is:
 1. A system to treat a patient having a heart and achest, the system comprising: a least one sensor monitoring cardiacactivity in the patient by detecting at least one of myocardial pumpactivity, myocardial mechanical activity, hemodynamics and organperfusion; a logic controller receiving signals and executing analgorithm stored in a non-transitory memory accessible by the logiccontroller which causes the system: determine whether the patient is ina pulseless electrical activity (PEA) condition; in response to thedetermination that the patient is in the PEA condition, determine apattern of myocardial motion or residual pulsatile blood flow occurringin the patient during the PEA condition and based on the receivedsignals; and in response to the determined pattern and during the PEAcondition, generating a command to repeatedly apply a phasic therapy tothe patient, wherein the command causes or prompts the application ofthe phasic therapy repeatedly and in synchrony with the pattern of theactual myocardial motion or the pulsatile blood flow.
 2. The system ofclaim 1 wherein the logic controller executes the algorithm to furthercause the system to: sense the actual myocardial motion or residualpulsatile blood during the application of the phasic therapy; change theapplication of the phasic therapy, and determine if the changedapplication of the phasic therapy improves the myocardial pump activityor residual pulsatile blood flow.
 3. The system of claim 1 wherein thecommand to cause or prompt the application of the phasic therapy causesthe phasic therapy to be applied during at least a portion of anejection phase of the heart and ceasing the application of the phasictherapy during at least a portion of a relaxation phase of the heart. 4.The system of claim 1 further comprising a medical device configured toapply a compressive force to the chest in response to the command. 5.The system of claim 4 wherein the compressive force is applied to atleast one of a sternal, a parasternal or an intercostal area of thechest.
 6. The system of claim 4 wherein the compressive force is appliedduring each ejection phase of the heart in which the phasic therapy isapplied.
 7. The system of claim 4 wherein the compressive force orelectrical shock is applied during less than all of the ejection phaseof the heart during a period in which the phasic therapy is applied. 8.The system of claim 4 wherein the command causes the compressive forceto be applied during a predetermined portion of the ejection phase andthe compressive force to cease during another portion of the ejectionphase.
 9. The system of claim 8 further comprising a medical deviceconfigured to actively lift or actively decompress the chest during therelaxation phase and during the cessation of the compressive force, andin response to the command.
 10. The system of claim 1 further comprisinga medical device configured to apply, in response to the command, atleast one of active chest decompression, abdominal compression,ventilation, phasic limb-compression, myocardial electrical stimulation,intravascular fluid shifting, intravascular or internal visceral ballooninflation-deflation, and application of transthoracic electromagneticirradiation.
 11. The system of claim 10 wherein the command causes thelifting or decompression to be applied during an entirety of therelaxation phase.
 12. The system of claim 10 wherein the medical deviceis at least one of a mechanical compression device; an inflatable vest,a nerve or muscle stimulator; and a suction basedcompression-decompression device.
 13. The system of claim 1 wherein theat least one sensor is a plurality of sensors each monitoring thecardiac activity and the algorithm causes the logic controller to:analyze the signals from the sensors during the application of thephasic therapy to determine which of the sensors generate signalsrepresentative of the myocardial motion or the pulsatile blood flow;select the signals from at least one of the sensors producing signalsrepresentative of the myocardial motion or the pulsatile blood flow todetermine the pattern, and use the selected signals to determine thepattern of myocardial motion or residual pulsatile blood flow.
 14. Thesystem of claim 13 wherein the signals from the sensors are analyzed andthe selection of the signals are performed periodically while thepatient is in the PEA condition.
 15. The system of claim 1 furthercomprising a ventilator and the logic controller executing the algorithmcauses the ventilator to apply ventilations, gas flow or airway pressureof the patient in the PEA condition.
 16. The system of claim 1 whereinthe at least one sensor includes a sensor of echocardiography, Dopplerultrasonography, plethysmography and phonocardiography.
 17. The systemof claim 1 wherein the at least one sensor is an array of sensorsapplied to the patient.
 18. A system to treat a patient having a heartand a chest, the system comprising: a least one sensor monitoringcardiac activity in the patient by detecting at least one of myocardialpump activity, myocardial mechanical activity, hemodynamics and organperfusion; a logic controller receiving signals and executing analgorithm stored in a non-transitory memory accessible by the logiccontroller which causes the system to: determine whether the patient isin a pulseless electrical activity (PEA) condition; in response to thedetermination that the patient is in the PEA condition, determine anatural rate myocardial activity in the patient during the PEA conditionand without the application of any phasic therapies, and thedetermination is based on the received signals; and after determiningthe natural rate, generating a command to repeatedly apply a phasictherapy to the patient, wherein the command causes or prompts theapplication of a phasic therapy at a rate different than the sensednatural rate of myocardial activity.
 19. The system of claim 18 whereinthe rate is faster than the sensed natural rate of myocardial activity.20. The system of claim 18 further comprising a medical deviceconfigured to apply a compressive force to the chest in response to thecommand.
 21. The system of claim 20 further comprising a medical deviceconfigured to actively lift or actively decompress the chest during therelaxation phase and during the cessation of the compressive force, andin response to the command.
 22. The system of claim 18 furthercomprising a medical device configured to apply, in response to thecommand, at least one of active chest decompression, abdominalcompression, ventilation, phasic limb-compression, myocardial electricalstimulation, intravascular fluid shifting, intravascular or internalvisceral balloon inflation-deflation, and application of transthoracicelectromagnetic irradiation.
 23. The system of claim 22 wherein themedical device is at least one of a mechanical compression device; aninflatable vest, a nerve or muscle stimulator; and a suction basedcompression-decompression device.
 24. The system of claim 18 furthercomprising a ventilator and the logic controller executing the algorithmcauses the ventilator to apply ventilations, gas flow or airway pressureof the patient in the PEA condition.
 25. The system of claim 18 whereinthe at least one sensor includes a sensor of echocardiography, Dopplerultrasonography, plethysmography and phonocardiography.
 26. The systemof claim 18 wherein the at least one sensor is an array of sensorsapplied to the patient.
 27. A system to treat a patient having a heartand a chest, the system comprising: a least one sensor monitoringcardiac activity in the patient by detecting at least one of myocardialactivity and pulsatile blood flow; a logic controller receiving signalsfrom the at least one sensor and generating control commands forcontrolling one or more phasic therapies and synchronizing the one ormore phasic therapies with the monitored cardiac activity in thepatient; and wherein the logic controller executes an algorithm storedin memory associated with the logic controller, wherein the algorithmcauses the logic controller to generate commands to vary patterns of theapplication of the one or more phasic therapies, and determine one ofthe patterns of phasic therapies corresponding to a certain level of atmyocardial activity or pulsatile blood flow.
 28. The system of claim 27wherein the at least on sensor is a plurality of sensors and the logiccontroller executes the algorithm to select one or more of the sensorsgenerates signals representative of myocardial activity or pulsatileblood flow, and thereafter uses the signals from the selected one ormore sensors to determine the one of the patterns.
 29. A system to treata patient having a heart and a chest, the system comprising: a least onesensor monitoring cardiac activity in the patient by detecting at leastone of myocardial pump activity, myocardial mechanical activity,hemodynamics and organ perfusion; a logic controller executes analgorithm stored in a non-transitory memory accessible by the logiccontroller which causes the logic controller to: determine whether thepatient is in a pulseless electrical activity (PEA) condition; monitorcardiac activity in the patient by detecting with the at least onesensor at least one of myocardial pump activity, myocardial mechanicalactivity, hemodynamics and organ perfusion; receive the signals from theat least one sensor and, based on the signals, synchronize one or morephasic therapies cyclically applied to the patient; varying the cyclicalapplication of one or more of the phasic therapies; detect changes in atleast one of the sensed myocardial pump activity, myocardial mechanicalactivity, hemodynamics and organ perfusion due to the variations in thecyclical application of the one or more phasic therapies; and determineat least one of the variations of the phasic therapies corresponding toa desired level of at least one of sensed myocardial pump activity,myocardial mechanical activity, hemodynamics and organ perfusionhemodynamics and organ perfusion.
 30. The system of claim 29 wherein thealgorithm further causes the controller to compare at least one of thesensed myocardial pump activity, myocardial mechanical activity,hemodynamics and organ perfusion hemodynamics and organ perfusion withand without application of the phasic therapies to determine which ofthe phasic therapies optimally augments hemodynamics or perfusion.